Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
研究概览
简要总结
This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a specifically on the needs of caregivers of people with dementia composed new short-term psychotherapeutical intervention.
详细描述
This prospective study will be offered to caregivers from the out patient clinic of the Department of Psychosomatic Medicine of the University Rostock Medical Center. In a first pilot study with 10 participants without control group, we tested the feasability and acceptance of the program (completed 2/2015). From 4/2015 a phase IIa study started with 10 participants in the intervention group and 10 in the control groups (will be organized by waiting list). The program consists of two modules of caregiver education followed by ten psychotherapeutic group modules. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module. Primary outcomes are the feasibility, acceptance and the effect on caregiver burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •caregiver of a person with dementia
- •willing to participate in all 12 modules of the program
排除标准
- •current psychotherapy or antidepressive medication for less than 6 month
- •major depression
结局指标
主要结局
Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
时间窗: before intervention, 0 and 3 month after end of intervention
SWE, a german self-efficacy self-rating scale, will be used for self-efficacy measurement AND ADS (German Version of the CES-D Scale) for measurement for symptoms of depression
次要结局
- reduction of perceived burden of care(before intervention, 0 and 3 month after end of intervention)
研究者
Ingo Kilimann
Neurologist
University of Rostock